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With regard to the substantial clinical improvement criterion, the applicant asserted that sabizabulin represents a substantial clinical improvement over existing technologies because sabizabulin has been shown to significantly improve clinical outcomes relative to other COVID-19 treatments because in a randomized, multicenter placebo-controlled phase 3 clinical trial, sabizabulin was associated with: reduction of least one clinically significant adverse event (SAE)

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Bajaj JS, Sheikh MY, Chojkier M, Balart L, Sherker AH, Vemuru R, Sussman NL, Vierling J, Morelli G, Anderson KE, Harris MS, Mullen KD